Scientific Presentations
Lesion Characteristics of Early Choroidal Neovascularization. The HOME Study: ForeseeHome® in AREDS2
Judy E. KimThe HOME study demonstrated that the distribution of lesion characteristics and visual acuity at the time of CNV detection in patients randomly assigned to the home device in addition to standard care is highly favorable. These attributes will likely lead to improved vision outcome following anti-VEGF treatment.
Qualifying to Use a Preferential Hyperacuity Perimetry Home Device Prior to Monitoring for Neovascular Age-related Macular Degeneration
Merina Thomas; Yulia Wolfson; Voraporn Chaikitmongkol; Susan B Bressler; Neil M BresslerThe data suggests that most patients who have the intermediate stage of AMD should produce a reliable test when first using a home device PHP and between 61% to 77% likely will pass a qualification test to initiate at home monitoring, among whom 88% to 99% likely will establish a baseline after 5 at-home tests to permit monitoring for progression to neovascular AMD.
The Home Monitoring of the Eye (HOME) Study: Potential implication of Findings on Management of Intermediate AMD Patients
Alexander J Brucker; AREDS II - HOME STUDYPersons at high risk for CNV benefit from the home monitoring strategy for earlier detection of CNV. The productivity of an office visit prompted by a device alert is far greater than a routine office visit in identifying new onset CNV.
SCANLY Home OCT FDA Intended Use
SCANLY Home OCT has not been approved by FDA for use other than described in the following Intend Use: The Notal Vision Home Optical Coherence Tomography (OCT) System is an Artificial Intelligence (AI)-based Home Use device indicated for visualization of intraretinal and subretinal hypo-reflective spaces in a 10 by 10-degrees area centered on the point of fixation of eyes diagnosed with neovascular age-related macular degeneration (NV-AMD). In addition, it provides segmentation and an estimation of the volume of hypo-reflective spaces. The Notal Home OCT device is intended for imaging at home between regularly scheduled clinic assessments and not intended to be used to make treatment decisions or replace standard-of care regularly scheduled examinations and clinical testing as needed, including in-office imaging and assessments for changes in vision, by an ophthalmologist.
See also Warnings and Precautions.
ForeseeHome FDA Intended Use
ForeseeHome has not been approved by FDA for use other than described in the following Indication for Use: The ForeseeHome is intended for use in the detection and characterization of central and paracentral metamorphopsia (visual distortion) in patients with age-related macular degeneration as an aid in monitoring progression of disease factors causing metamorphopsia including, but not limited to choroidal neovascularization (CNV). It is intended to be used at home for patients with stable fixation.
